Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain (ROSA)

Dr. Santiago Palacios

Status and phase: Unknown; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Other: Placebo; Drug: Prasterone 6.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04898556

IP-ROSA2020

2020-004517-12 (EudraCT Number)

Details and patient eligibility

About

A prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. The efficacy of Prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.

Full description

A sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen.

At the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. Through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.

Enrollment: 50 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.
• Women with moderate to severe vulvar / vestibular pain
• Women without symptoms or signs of acute vaginal infection.
• Women without symptoms of urinary infection and a negative urine strip result.
• Woman willing to carry out the study procedures and comply with the visits.
• Woman who signs the Informed Consent.

Exclusion criteria

• Hormone treatment in the last three months for vulvovaginal atrophy
• Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
• Laser treatment in the last 6 months.
• Acute and recurrent urinary tract infections in the last 3 months.
• Acute genital infections (herpes, candida, etc)
• Personal history of cancer at any level
• Present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion)
• Decompensated non-communicable chronic diseases (Diabetes Mellitus, Heart Disease ...)
• Participation in a clinical study 3 months before inclusion or during this study.
• Hypersensitivity to the active principle or any of the excipients
• Undiagnosed vaginal bleeding.
• Untreated endometrial hyperplasia
• Acute liver disease or a history of liver disease while liver function tests remain impaired.
• Current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Known thrombophilic disorders (protein C, protein S, or antithrombin deficiency)
• Current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction)
• Porphyria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Active Treatment

Active Comparator group

Description:

Patients who will undergo treatment with Intrarosa (Prasterone 6.5mg) in ovules, will apply one ovule a day before going to bed for 12 weeks.

Treatment:

Drug: Prasterone 6.5 MG

Control Group

Placebo Comparator group

Description:

Patients who will not undergo any treatment for vulvovaginal atrophy for 12 weeks.

Treatment:

Other: Placebo